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Role of Fibrocytes in Chronic Obstructive Pulmonary Disease (FIREBROB)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01196832
First received: June 1, 2010
Last updated: October 29, 2014
Last verified: October 2014

June 1, 2010
October 29, 2014
March 2011
September 2016   (final data collection date for primary outcome measure)
  • Number of circulating blood fibrocytes [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Sampling of blood in Chronic obstructive pulmonary disease patients
  • Number of circulating blood fibrocytes [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Sampling of blood in Chronic obstructive pulmonary disease patients
Same as current
Complete list of historical versions of study NCT01196832 on ClinicalTrials.gov Archive Site
  • Characterization of fibrocytes [ Time Frame: Day 1 and at 2 months ] [ Designated as safety issue: No ]
    Sampling of blood
  • Differenciation of blood fibrocytes [ Time Frame: Day 1 and at 2 months ] [ Designated as safety issue: No ]
    Sampling of blood
  • Chemotactism of blood fibrocytes [ Time Frame: Day 1 and at 2 months ] [ Designated as safety issue: No ]
    Sampling of blood
  • Number of exacerbation [ Time Frame: 12 months after V2 ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 12 months after V2 ] [ Designated as safety issue: Yes ]
  • Annual decline of ventilatory function [ Time Frame: 12 months after V2 ] [ Designated as safety issue: Yes ]
  • Characterization of fibrocytes [ Time Frame: Day 1 and at 2 months ] [ Designated as safety issue: No ]
    Sampling of blood
  • Differenciation of blood fibrocytes [ Time Frame: Day 1 and at 2 months ] [ Designated as safety issue: No ]
    Sampling of blood
  • Chemotactism of blood fibrocytes [ Time Frame: Day 1 and at 2 months ] [ Designated as safety issue: No ]
    Sampling of blood
Not Provided
Not Provided
 
Role of Fibrocytes in Chronic Obstructive Pulmonary Disease
Role of Fibrocytes in the Bronchial Remodeling of Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease (COPD) is a frequent airway disease characterized by both bronchial inflammation and remodelling.

Bronchial mucosa is infiltrated by macrophages, neutrophils and lymphocytes. In addition, the number of eosinophils can be also increased during exacerbation.

Airway remodelling is an abnormal tissue repair following bronchial inflammation, which contributes to none reversible pathological features, such as bronchial and peri-bronchial fibrosis. It also influences the prognosis of COPD and its mechanisms remain largely unknown. The role of fibrocytes has been demonstrated in the pathophysiology of asthma, lung fibrosis or pulmonary hypertension. However, the recruitment of blood fibrocytes and their involvement in COPD airway remodelling remain unknown.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Male or female aged more than 40 years

  • Chronic obstructive pulmonary disease (CODP) patients recruited during hospitalization in Intensive care unit or as outpatients in the clinical investigation centre of the CHU de Bordeaux.
  • Control group: subjects without any history of lung disease and with normal lung function testing recruited following a normal lung function testing in the clinical investigation centre of the CHU de Bordeaux.
Chronic Obstructive Pulmonary Disease
  • Procedure: blood sample
    blood sample for fibrocytes analysis
  • Procedure: Clinical and functional evaluation
    Plethysmography, Carbon monoxide capacity of transfer , arterial gaz
  • Chronic obstructive pulmonary disease patients

    COPD patients with exacerbation will be recruited during hospitalization in Intensive care unit or as outpatients in the clinical investigation centre of the CHU de Bordeaux.

    Inclusion visit: blood sample for fibrocytes analysis. Second visit 2 months ± 7 days after the exacerbation: clinical and functional evaluation (plethysmography, TLCO, arterial gaz), blood sample for fibrocytes analysis.

    Interventions:
    • Procedure: blood sample
    • Procedure: Clinical and functional evaluation
  • Control group
    Subjects without any history of lung disease and with normal lung function testing
    Intervention: Procedure: blood sample
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
November 2016
September 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients: diagnostic of Chronic obstructive pulmonary disease (COPD) exacerbation.
  • Control group: subjects without any history of lung disease and with normal lung function testing. Subjects will be separated in 2 sub-groups according to smoking history (Never smokers, smokers (former or current) and paired to patients according to age and sex.
  • Written informed consent

Exclusion Criteria:

  • Subject without any social security or health insurance
  • Asthma, lung fibrosis or idiopathic pulmonary hypertension
  • Chronic viral infections (hepatitis, HIV)
Both
40 Years and older
Yes
Contact: Patrick BERGER, PUPH (0)5 57 65 65 13
Contact: David LEGROS (0)5 57 65 65 13 david.legros@chu-bordeaux.fr
France
 
NCT01196832
CHUBX 2010/05
No
University Hospital, Bordeaux
University Hospital, Bordeaux
Not Provided
Principal Investigator: Patrick BERGER, PUPH University Hospital Bordeaux (France)
University Hospital, Bordeaux
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP